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Pre-emptive Analgesia With Qutenza in Lower Limb Amputation

Information source: NHS Greater Glasgow and Clyde
ClinicalTrials.gov processed this data on November 27, 2014
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Neuropathic Pain; Lower Limb Amputation

Intervention: Qutenza (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: NHS Greater Glasgow and Clyde

Official(s) and/or principal investigator(s):
Emma L Aitken, MBChB, Principal Investigator, Affiliation: NHS Greater Glasgow and Clyde

Overall contact:
Emma L Aitken, MBChB, Phone: 01412111750, Email: EmmaAitken@nhs.net

Summary

Neuropathic (nerve pain) following amputation of a limb is very common, affecting 60-80% of patients (Sherman et al, 1984). It can prolong their recovery making it difficult to fit protheses and mobilise. Current treatment options are limited and existing painkillers have significant side effects. Nevertheless there is some evidence that pre-emptive analgesia (pain relief provided prior to the surgery) has additional benefits after the surgery (Ypsilantis & Tang, 2010) Qutenza (topical capsaicin 8%)is a novel analgesic agent which is applied directly onto the skin. It works by desensitising to pain receptors in the skin (Nolano et al., 1999) and has been shown to be effective in reducing neuropathic pain in other conditions (Backonja et al., 2008) We propose to evaluate the use of Qutenza for pre-emptive analgesia in patients undergoing amputation of a limb. This is a small, pilot, randomised controlled study of 30 patients undergoing lower limb amputation who will have Qutenza or active control applied prior to surgery. They will be followed up for 12 weeks post-operatively with regular assessment of pain scores, quality of life and wound healing.

Clinical Details

Official title: The Role of Pre-emptive Analgesia With Qutenza (Topical Capsaicin 8%) in Preventing Neuropathic Pain Following Lower Limb Amputation: a Pilot Randomised Controlled Study

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Chronic neuropathic pain

Secondary outcome:

Neuropathic pain

Acute post-operative pain

Wound healing

Quality of life

Safety and tolerability

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- All adult patients >18 years old undergoing lower limb amputation

Exclusion Criteria: Traumatic amputation Severe active sepsis in non-viable limb Illness necessitating urgent surgery <24 hours after admission to hospital Hypersensitivity to Qutenza, Emla or any of the excipients Broken skin or active ulceration at the site of application Severe uncontrolled hypertension (systolic BP >200) Proven cardiac event during the preceding 3 months Women who are pregnant or breast feeding Lack of capacity or inability to provide informed consent Declines participation in the study

Locations and Contacts

Emma L Aitken, MBChB, Phone: 01412111750, Email: EmmaAitken@nhs.net

Western Infirmary, Glasgow, Lanarkshire G116NY, United Kingdom; Not yet recruiting
Emma L Aitken, MBChB, Phone: 01412111750, Email: EmmaAitken@nhs.net
David B Kingsmore, MBChB MD, Phone: 01412111750, Email: david.kingsmore@ggc.scot.nhs.uk
Emma L Aitken, MBChB, Principal Investigator
Additional Information

Starting date: February 2013
Last updated: December 10, 2012

Page last updated: November 27, 2014

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